Trial Outcomes & Findings for Evaluation of Labeling Comprehension and Performance of a New Blood Glucose Meter System (NCT NCT00804596)

Last Updated: 2016-02-29

Results Overview

Study staff rated participants on their success at performing Blood Glucose (BG) testing and other system features after subjects read product labeling. The rating scale was: 1. Successful in performing tasks correctly without assistance 2. Successful after being referred to user instructions 3. Successful after verbal assistance or review of part of user instructions (Similar to review of a specific function during a Customer Service call.) 4. Unsuccessful (Incorrectly performed part of the testing regimen or required intervention by study staff.)

Recruitment status

COMPLETED

Study phase

Target enrollment

74 participants

Primary outcome timeframe

1-2 hours

Results posted on

2016-02-29

Participant Flow

5 subjects signed informed consents but did not meet inclusion/exclusion criteria so were not considered enrolled in the study.

Participant milestones

Participant milestones
Measure	Subjects With Diabetes Subjects with diabetes and healthcare professionals (HCPs) use a new blood glucose monitoring system with subject capillary blood.
Overall Study STARTED	74
Overall Study COMPLETED	74
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of Labeling Comprehension and Performance of a New Blood Glucose Meter System

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Subjects With Diabetes n=74 Participants Subjects with diabetes and healthcare professionals (HCPs) use a new blood glucose monitoring system with subject capillary blood.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	64 Participants n=5 Participants
Age, Categorical >=65 years	10 Participants n=5 Participants
Sex: Female, Male Female	40 Participants n=5 Participants
Sex: Female, Male Male	34 Participants n=5 Participants
Region of Enrollment United States	74 participants n=5 Participants

PRIMARY outcome

Timeframe: 1-2 hours

Population: per protocol

Outcome measures

Outcome measures
Measure	Subjects With Diabetes n=74 Participants Subjects with diabetes and healthcare professionals (HCPs) use a new blood glucose monitoring system with subject capillary blood.
Percentage of Participants Rated as <=3 (Comprehension of Labeling) Perfom blood glucose measurement	100 percentage of participants
Percentage of Participants Rated as <=3 (Comprehension of Labeling) Connect meter to computer via USB port	100 percentage of participants
Percentage of Participants Rated as <=3 (Comprehension of Labeling) Select 'Before'/"After' meal in Autolog feature	100 percentage of participants
Percentage of Participants Rated as <=3 (Comprehension of Labeling) Access electronic user guide on Apollo meter	100 percentage of participants
Percentage of Participants Rated as <=3 (Comprehension of Labeling) Set date/time to current by selecting Y at prompt	100 percentage of participants
Percentage of Participants Rated as <=3 (Comprehension of Labeling) Remove meter from computer	100 percentage of participants
Percentage of Participants Rated as <=3 (Comprehension of Labeling) Perform simulated BG test using control solution	100 percentage of participants
Percentage of Participants Rated as <=3 (Comprehension of Labeling) Turn on test strip port light (n=73)	100 percentage of participants
Percentage of Participants Rated as <=3 (Comprehension of Labeling) Access and review Logbook, Reports, and Summary	100 percentage of participants
Percentage of Participants Rated as <=3 (Comprehension of Labeling) Access and review Blood Sugar Trends	100 percentage of participants
Percentage of Participants Rated as <=3 (Comprehension of Labeling) Understand data for Before/After Meal and 14day	100 percentage of participants
Percentage of Participants Rated as <=3 (Comprehension of Labeling) Understand Average glucose value	100 percentage of participants
Percentage of Participants Rated as <=3 (Comprehension of Labeling) Understand BG number within target range	100 percentage of participants
Percentage of Participants Rated as <=3 (Comprehension of Labeling) Understand BG number above target range	100 percentage of participants
Percentage of Participants Rated as <=3 (Comprehension of Labeling) Understand BG number below target range	100 percentage of participants
Percentage of Participants Rated as <=3 (Comprehension of Labeling) Was able to turn meter off (n=73)	100 percentage of participants
Percentage of Participants Rated as <=3 (Comprehension of Labeling) Understand Apollo has no replaceable batteries	100 percentage of participants
Percentage of Participants Rated as <=3 (Comprehension of Labeling) Able to charge via USB port and verify charging	100 percentage of participants
Percentage of Participants Rated as <=3 (Comprehension of Labeling) Able to set date and time formats (n=73)	100 percentage of participants
Percentage of Participants Rated as <=3 (Comprehension of Labeling) Able to change 'Before Meal' target range(n=73)	100 percentage of participants

SECONDARY outcome

Timeframe: 1-2 hours

Population: Since each subject provided two blood glucose (BG) meter results, 2x74 (or 148) subject BG test results were possible. For each subject blood sample, a healthcare professional (HCP) provided two BG meter results so that 2x74 (or 148) BG results were possible for HCP test results.

Subjects with diabetes and healthcare professionals (HCPs) used a new Blood Glucose Monitoring System (BGMS) with subject capillary blood. The BGMS has programmed algorithms to provide results equivalent to either serum/plasma or whole blood glucose methods; this study evaluated results equivalent to plasma lab methods. All results were compared to a lab glucose method - Yellow Springs Instrument (YSI) Analyzer. BG results were obtained in duplicate from subjects using three lots of Contour Blood Glucose strips, evenly distributed among the subjects.

Outcome measures

Outcome measures
Measure	Subjects With Diabetes n=74 Participants Subjects with diabetes and healthcare professionals (HCPs) use a new blood glucose monitoring system with subject capillary blood.
Number of Capillary Blood Results Within +/- 15mg/dL or +/- 20% of Laboratory Glucose Method Subjects: Test Results (n=148)	146 Number of Duplicate Results (n=74x2)
Number of Capillary Blood Results Within +/- 15mg/dL or +/- 20% of Laboratory Glucose Method HCPs: Test Results (n=148)	143 Number of Duplicate Results (n=74x2)

Adverse Events

Subjects With Diabetes

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Subjects With Diabetes n=74 participants at risk Subjects with diabetes and healthcare professionals (HCPs) use a new blood glucose monitoring system with subject capillary blood.
General disorders Cold or flu-like symptoms during the home-use portion of the study	5.4% 4/74 • Number of events 4

Additional Information

Senior Clinical Research Scientist

Ascensia Diabetes Care

Phone: 574-257-3040

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60